What is NDC 76420-008?

76420-008 is the product NDC for Bupivacaine Hydrochloride, Bupivacaine hydrochloride 5 mg/mL injection, solution, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bupivacaine Hydrochloride?

70 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bupivacaine Hydrochloride NDC 76420-008

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0008Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
76420-008-10	7642000081076420000810	10 mL in 1 VIAL, SINGLE-DOSE (76420-008-10)Marketed from Jan 16, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Bupivacaine Hydrochloride
Generic name (nonproprietary): bupivacaine hydrochloride
Active ingredients: Bupivacaine hydrochloride — 5 mg/mL
Dosage form: Injection, Solution
Route: Epidural, Intracaudal
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203895
Marketing start: Nov 5, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 76420-008_ead08199-44c1-c795-e053-2995a90a7e08SPL ID ead08199-44c1-c795-e053-2995a90a7e08SPL set ID a60303c2-5217-41db-855b-83fa2a749da2RxCUI 1724880UNII 7TQO7W3VT8
Pharmacologic class: Amide Local Anesthetic

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N476420000810 followed by a unit qualifier and the quantity

Package 76420-0008-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 12, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Bupivacaine hydrochloride injection, USP is indicated for the production of local or regional anesthesia or analgesia for surgery, oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS .) Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of bupivacaine hydrochloride injection, USP in these patients. Bupivacaine hydrochloride injection, USP is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS . The routes of administration and in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-008

What is NDC 76420-008?: 76420-008 is the product NDC for Bupivacaine Hydrochloride, Bupivacaine hydrochloride 5 mg/mL injection, solution, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bupivacaine Hydrochloride.
What is the active ingredient?: Bupivacaine hydrochloride.
Who is the labeler?: Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bupivacaine Hydrochloride?: 70 other product NDCs are listed under this name. See all Bupivacaine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Bupivacaine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural	Anthea Pharma Private Limited	83854-004	83854-0004-1083854-0004-11
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 7.5 mg/mL	Injection, SolutionEpidural, Retrobulbar	Anthea Pharma Private Limited	83854-005	83854-0005-1083854-0005-11
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionPerineural	Anthea Pharma Private Limited	83854-006	83854-0006-01
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Intracaudal, Perineural	Anthea Pharma Private Limited	83854-039	83854-0039-1083854-0039-11
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionInfiltration, Perineural	Anthea Pharma Private Limited	83854-038	83854-0038-01
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural	Fosun Pharma USA Inc.	72266-264	72266-0264-10
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration	Fosun Pharma USA Inc.	72266-263	72266-0263-10
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration	ONESOURCE SPECIALTY PHARMA LIMITED	83270-162	83270-0162-10
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration	ONESOURCE SPECIALTY PHARMA LIMITED	83270-165	83270-0165-01
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural	ONESOURCE SPECIALTY PHARMA LIMITED	83270-163	83270-0163-10

All 71 Bupivacaine Hydrochloride NDCs

Other NDCs under ANDA 203895

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203895
Product	Strength	Form · route	Labeler	Product NDC
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration, Intracaudal	Eugia US LLC	55150-167
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration, Intracaudal	Eugia US LLC	55150-168
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Intracaudal	Eugia US LLC	55150-169
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Intracaudal	Eugia US LLC	55150-170
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 7.5 mg/mL	Injection, SolutionEpidural, Retrobulbar	Eugia US LLC	55150-171
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 7.5 mg/mL	Injection, SolutionEpidural, Retrobulbar	Eugia US LLC	55150-172
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration, Intracaudal	Asclemed USA, Inc.	76420-018